510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864422Substantially Equivalent

Raylor(tm) Mallet

Cedar Surgical, Inc., Minnetonka MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864422 is the FDA 510(k) clearance record for RAYLOR(TM) MALLET, a class I device, cleared for Cedar Surgical, Inc. on under FDA product code HWA (Impactor). FDA records list 17 510(k) clearances for Cedar Surgical, Inc., from to . As of , FDA records show no recalls naming K864422.

Clearance record

Decision date
Received
(14 days to decision)
Product code
HWA Impactor
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
Cedar Surgical, Inc. 15265 Minnetonka Blvd., Minnetonka MN
Third party review
No

Clearances, product code HWA

Trailing 12 months

FDA records hold no clearances under product code HWA in the trailing twelve months.

FDA records show no clearances under product code HWA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HWA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260